The manufacturing issues continue to mount for India’s Cadila Healthcare. The drugmaker, which last year was hit with an FDA warning letter for two of its…

The FDA, which has been on a campaign to get Indian drugmakers to conform with its regulations, slapped Unimark Remedies with another warning letter in which…

Dublin-based Mallinckrodt company has decided it needs a U.S. campus to consolidate workers picked up in an M&A spree, as well as some more manufacturing,…

The FDA recently issued another warning letter to Noven, a standalone operating subsidiary of Japan-based Hisamitsu Pharmaceuticals, for lapses at its Miami…

Sun Pharma continues to slog away at its remediation efforts at both its key plant in Halol as well at the four plants it got in its $4 billion buyout of…

A new report shows international regulators were unimpressed with Pfizer’s operations at a Hospira plant in India during a recent inspection.  

Portola has gotten an FDA CRL largely focused on manufacturing issues for AndexXa, its breakthrough anticoagulant reversal agent. It joins a number of other…

Pfizer has decided that it does not need the legacy distribution sites that it got with the $15 billion buyout of Hospira last year and so will close four…